Tasmanian immunisation program guidelines for authorised nurse immunisers

Introduction

Immunisation is the safest and most effective way to control many of the world’s most important infectious diseases. It has been the single most important advancement in public health over the last century saving more lives than any other health intervention.

Australia has a strong and internationally recognised National Immunisation Program (NIP), with a national average of over 90 per cent coverage for most childhood vaccines (DTPa, hepatitis B, MMR, Hib, and polio). Australia’s achievements in immunisation meet international goals set by the World Health Organization under the Global Vaccine Action Plan as outlined in the National Immunisation Strategy. 

Opportunities remain to improve vaccination rates for all ages both locally and internationally. Achieving high vaccination coverage rates requires a competent workforce as well as effective clinical governance arrangements for all immunisation programs which are clear, accountable, and effective, with business processes in place to monitor and evaluate performance and provide feedback.

In Tasmania, the Poisons Regulations 2018 allows registered nurses, midwives, and pharmacists, who have met the Tasmanian immunisation authorisation requirements, to possess and administer vaccines independently. In this document a registered health practitioner who has been approved to immunise independently is referred to as an Authorised Immuniser (AI).

In certain circumstances (i.e. a pandemic or major communicable disease outbreak) the Secretary of the Department of Health (DoH) or his or her delegate (usually the Director of Public Health) may also approve additional classes of health professionals to possess and administer vaccines without the direct supervision of a medical practitioner. 

Scope of these Guidelines: These Tasmanian Immunisation Program Guidelines (the ‘Guidelines’) provide guidance to organisations employing Registered Nurses / Midwives or pharmacists (those not employed within the pharmacy setting*), as Authorised Immunisers who are not under the direct supervision of a medical or nurse practitioner.

*Please see the Tasmanian Pharmacist Immunisation Program Guidelinesfor the vaccine scope, processes and additional considerations for Authorised Pharmacist Immunisers employed within the pharmacy settings in Tasmania.

Regulations

In Tasmania, Regulation 82[i] (c)&(d) of the Poisons Regulations 2018 allows registered nurses, midwives and pharmacists, who have met the Tasmanian authorisation requirements, and who have been approved by the Director of Public Health (DPH) to administer vaccines as listed in Schedule 4 to the Poisons List according to the immuniser’s health profession:

• Authorised Nurse/Midwife Immunisers - see Section 3. ‘Scope of Vaccination Practice’ - Table 1
• Pharmacist Immunisers – see Tasmanian Pharmacist Immunisation Program Guidelines 

An Authorised Immuniser (AI) may not independently provide vaccines unless they are working under an immunisation program that has been approved by the DPH.

Immunisation programs

Organisations are required to apply and have current immunisation program approval from the DPH before administering vaccines. 

The nominated Responsible Officer of the Organisation / Company is responsible for the program and for ensuring all employed AIs meet and maintain the requirements for authorisation. This includes policies and practices that support the delivery of safe immunisation services to the public.

Immunisation program approval enables organisations to:

• employ AIs to offer vaccination services 
• order NIP-funded and/or state-funded vaccines
• receive important vaccine updates, such as changes to vaccination schedule(s), new resources and changes to vaccination recommendations.

Immunisation program requirements

Immunisation programs must be administered in accordance with the relevant legislation and best practice guidance, this includes:

• Managing cold chain as per the National Vaccine Storage Guidelines - ‘Strive for 5’ – this guideline outlines required cold chain practices, including use of a purpose-built vaccine refrigerators, data loggers, temperature reporting, training, and other considerations. 
• Following clinical guidance outlined in the Australian Immunisation Handbook (AIH).
• Complying with the Australian Guidelines for the Prevention and Control of Infection in Healthcare.
• Ensuring that the requirements within these Guidelines are met and maintained when running off-site immunisation clinics, including that the clinical setting is appropriate for the administration of vaccines.
• AIs must have access to the Australian Immunisation Register (AIR) and the following resources (including for any off-site vaccination clinics):
• the Australian Immunisation Handbook
• the National Vaccine Storage Guidelines – ‘Strive for 5’
• National and State immunisation program schedules
• materials to support communication about vaccination, including Questions about vaccination and Sharing Knowledge About Immunisation.

Applying for program approval and renewal

Organisations can apply for or renew their immunisation program approval online via the Immunisation Provider Portal (IPP).

• The Responsible Officer for the organisation must complete an Immunisation Program Application available on the IPP.
• Organisations applying for program approval for the first time must complete the Australian Immunisation Register – Application to register as a vaccination provider form (IM004) with their application. 

This form should be emailed to the Immunisation team, Communicable Diseases Prevention Unit (CDPU) – [email protected] 

• Immunisation programs must be renewed annually.

Organisations and AIs must hold appropriate insurance for the administration of vaccines and provision of an immunisation service. AIs should consult with their insurance provider regarding insurance appropriate to their circumstances.

Authorised immuniser requirements

Organisations employing AIs to administer vaccines without a medical order, in accordance with the authorisation under regulation 82(c)&(d), must ensure that the AI: 

• Is currently registered with the Australian Health Practitioner Regulation Agency (Ahpra) 
• has current approval from the Secretary, DoH (or his or her delegate) to administer vaccines independently, as per their approved scope 
• administers vaccines only as part of an approved immunisation program 
• completes a cardio-pulmonary resuscitation (CPR) update as per Australian Resuscitation Council (ARC) guidelines annually. This must include a paediatric component if the program provides childhood immunisations. 
• is competent to manage and report an Adverse Event Following Immunisation (AEFI) 
• refers people with contraindications to vaccines to a medical practitioner. 

Immunisation scope of practice

AIs must renew their authorisation to practice each year in line with the guidelines for ‘Applying for Immuniser Authorisation in Tasmania’.

Health practitioners registered by Ahpra have a legal obligation to perform within their scope of practice according to the education and training they have received, and within any regulatory, legislative, national policy or standards, codes and guidelines for their profession. 

The scope of vaccines that Nurses and Midwives are authorised to administer, and the circumstances in which they may administer these vaccines, are outlined in Tables 1. 

Pharmacists should refer to the Tasmanian Pharmacist Immunisation Program Guidelines for the vaccine scope, processes and conditions for Authorised Pharmacist Immunisers.

Table 1: Diseases for which Authorised Immunisers (Nurses and Midwives) may administer vaccines 

Approval for authorised immunisers to immunise with these vaccine(s) includes:

• Immunisation of children and adults as per the recommendations in the Australian Immunisation Handbook (AIH).

But excludes (i.e out of scope): 

• Immunisation for tetanus prophylaxis related to wound management. Tetanus prone wounds should be reviewed in a medical consultation.
• Immunisation for travel purposes.
• Immunisation of contacts in the event of an outbreak unless directed by the DPH.
• Immunisation with immunoglobulin preparations unless directed by the DPH.
  1. Supervision of Registered Health Practitioners by Authorised Immunisers[MS9] 

Where a case of vaccine preventable disease (e.g. Hepatitis A, Measles and Meningococcal Infection) is notifiable to the DPH under the Public Health Act 1997, the DoH will provide advice on the further management of the case and contacts.

*COVID-19 vaccines

The Australian Immunisation Handbook (AIH) now contains a dedicated COVID-19 chapter, which includes vaccine recommendations and information on the formulations currently available in Australia. All staff who administer COVID-19 vaccines must remain up to date with this content including the section on the use of multi-dose vials. 

^Smallpox vaccines

Limited to third generation smallpox vaccines, namely JYNNEOS^® (MVA-BN), in specified practices only and with specific approval from the DPH.

^#Typhoid vaccine

Limited to parenteral monovalent typhoid vaccine (Typhim Vi^®) or combination typhoid Vi polysaccharide/hepatitis A vaccine (Vivaxim^®) for occupational health indications, only in specified locations and with specific approval from the DPH.

Administration of adrenaline

In addition, Regulation 82(b) of the Poisons Regulations 2018 states that that a person who is a registered nurse or midwife may, administer a substance listed in Schedule 3 of the Poisons List. 

This includes the administration of adrenaline (1:1000) in the event of anaphylaxis. 

A pharmacist or intern pharmacist (pharmacy trainee) may supply a Schedule 3 substance (adrenaline) under Regulation 58(2) of the Poisons Regulations 2018. In this instance ‘supply’ means either, or both, provide and/or administer.

In accordance with Regulation 82(e) of the Poisons Regulations 2018 an experienced Authorised Immuniser (see definition below) may only supervise the administration of a vaccine by another health practitioner when the other health practitioner is undertaking an approved immunisation education program or has been approved to administer vaccines specified by the DPH. 

• An experienced AI is defined as having had a minimum of two years recent clinical experience administering National Immunisation Program (NIP) vaccines, to all age groups (infants, children and adults).

The regulations do not allow AIs to prescribe vaccines for another health practitioner to administer, except in specific circumstances, approved by the DPH under Regulation 82(e)(ii)&(f)(ii), for example, pandemic or major communicable disease outbreaks. 

If a health practitioner is not an AI and is administering vaccines, it must be under the direction of a medical practitioner.

For further information regarding Pharmacy Immunisation Programs and Authorised Pharmacist Immunisers, please refer to the ‘Tasmanian Pharmacist Immunisation Program Guidelines’.

Equipment

All equipment should comply with the recommendations contained in the AIH and Strive for 5 documents, and should include:

• an anaphylaxis response kit 
• purpose-built vaccine refrigerators with an automated temperature data logger 
• coolers, data loggers, ice packs and insulation materials suitable for off-site vaccination clinics or for transporting vaccines
• all necessary consumables required for vaccine administration
• a sharps container suitable for the disposal of clinical waste, including used syringes and needles.

Anaphylaxis response kit

An anaphylaxis response kit must be readily accessible when administering vaccines. All equipment should comply with the recommendations in the online version of the AIH, and include:

• adrenaline 1:1000 (minimum of three ampoules). Expiry dates are regularly checked; discard and replace expired stock and replenish stock after use
• a minimum of three 1 mL syringes and 25 mm length needles for intramuscular injection
• a pen, paper and stopwatch to record time of administration of adrenaline; alternatively, time of vaccine administrated may be documented and provided to the client
• a laminated copy of table ‘Doses of intramuscular 1:1000 adrenaline for anaphylaxis’ as per the current edition of the AIH, noting weight and age-specific doses required
• a laminated copy of ‘Recognition and treatment of anaphylaxis’ 
• an emergency response protocol (preferably laminated and on display) identifying assigned roles and responsibilities. All clinical and non-clinical staff should be aware of the emergency response protocol, and their roles and responsibilities in the event of an emergency.

Where adrenaline ampoules are unavailable, an adrenaline autoinjector may be kept in an anaphylaxis response kit, however, this is not preferred noting that autoinjectors are single use only, do not allow for dose variation or repeated doses and generally have a short expiry (12-24 months).

Refer to guidance in the AIH regarding the use of autoinjectors in vaccination services.

Policies and procedures to support immunisation service delivery

Protocols and processes

AIs must have a process to ensure they remain current with the AIH and Strive for 5 to inform their practice. Additionally, they must ensure they practice according to these Guidelines, and any other key resources.

Organisations providing immunisation service(s) must have documented policies and/or procedures in place to support a safe, high-quality service, including:

• Checking of anaphylaxis response kit
• Monitoring of vaccine storage systems 
• Managing the transport of vaccines when providing clinics off site
• Respond to a cold chain breach
• Back-up plan for vaccine storage during power failures
• Pre-screening assessment process
• Consent process
• When and how to seek further advice following outcome of screening process
• Routine immediate post-vaccination observation and management 
• Responding to a needle stick injury
• Responding to adverse event reports
• Managing anaphylaxis and vasovagal (syncope) episodes
• Documentation and record keeping including reporting of vaccination on the AIR
• Disposal of infectious and non-clinical waste
• Complaints process

Off-site vaccination clinics

Where off-site vaccination services are conducted, organisations and AIs are responsible for ensuring all requirements within these guidelines are met and maintained, and the clinical setting is appropriate for the administration of vaccines. The following conditions must be met when operating off-site vaccination services:

• adhere to the requirements of the AIH and Strive for 5, including for any equipment and cold chain requirements.
• ensure that the immunisation space allows for privacy and is of sufficient size to accommodate the patient (including space to manage an adverse event), an accompanying person and the authorised immuniser.
• ensure that in addition to the authorised immuniser, that another person who holds current first aid and cardiopulmonary resuscitation (CPR) qualification is also present when the vaccines are administered and during the post-vaccination period.
• ensure that patients are monitored during the post-vaccination period within line of sight of the AI or other first aid and CPR trained staff member for a minimum of 15 minutes post-vaccination.
• ensure that an emergency response protocol and an anaphylaxis response kit which complies with the recommendations of the AIH is accessible during sessions.
• ensure robust clinical documentation, including that all vaccines administered are recorded on the AIR.

Emergency response protocol

An emergency response protocol must be kept as part of the anaphylaxis response kit (preferably laminated and on display or easily accessible during off-site vaccination clinics). The protocol should identify assigned roles and responsibilities of staff members. 

The emergency response protocol should ensure that:

• systems are in place to regularly review the anaphylaxis response kit and emergency response protocol
• all AIs have current CPR and maintain continuing professional development in the management of AEFI
• vaccinees are monitored for at least 15 minutes after vaccine administration.

Adverse events following immunisation (AEFI) 

Equipment necessary for the management of anaphylaxis and protocols, including the emergency response protocol, should be checked and available before each immunisation session, regardless of the setting (including mobile or off-site vaccination services). Staff involved in vaccination sessions must be aware of their roles and responsibilities, including after-care or emergency response. 

Individuals (or their parent and/or guardian) must be informed about the potential side effects of vaccination as a component of obtaining informed consent, including how to manage them, and who to notify of delayed adverse events that may occur once they have left the premises.

Reporting adverse events following immunisation and vaccine administration errors

AIs must report any AEFI to the Immunisation team, CDPU. This also includes any vaccine administration errors (VAE), for example giving expired vaccines, incorrect intervals between vaccines, incorrect age for vaccine etc. The requirements and forms for reporting an AEFI or VAE are available on the DoH Immunisation webpage; completed AEFI forms must be returned via email to [email protected].

AEFI surveillance is conducted by the CDPU and the Therapeutic Goods Administration (TGA) to establish vaccine safety in Australia. CDPU supports consumers and providers to complete a report and provides advice after individuals who have experienced an AEFI. Providing information about an AEFI to CDPU will help detect potential problems with vaccines or systems as early as possible and, will help to deliver safe vaccination program in Tasmania.

Maintaining cold chain

All immunisation providers must follow the principles of safe vaccine storage and cold-chain management to ensure clients receive the most effective and potent vaccines possible.

Immunisation providers are required to maintain vaccines in a manner that is consistent with the recommendations in Strive for 5, noting this is a condition to receiving program approval. This also includes off-site immunisation clinics.

Reporting a cold chain breach

• Cold chain breaches involving government funded vaccines must be reported to the Immunisation Team, CDPU as soon as possible. This does not include temperature deviations where the temperature reaches a maximum of up to +12°C for ≤15 minutes. Any temperature deviations below +2°C must be reported to the CDPU.
• Cold chain breaches involving COVID-19 vaccines must be reported to the Vaccine Operations Centre (VOC) on 1800 318 208.

Pre-vaccination assessment and consent

Any vaccine impacted by a cold chain breach should be immediately isolated and retained within a monitored vaccine refrigerator and be clearly labelled with “do not use” until a member of the Immunisation Unit has conducted a thorough assessment. 

The CDPU Immunisation Unit can be contacted via the Public Health Hotline on 1800 671 738.

In the event of a cold chain breach related to privately purchased vaccine stock (i.e. non-NIP vaccines), the vaccine manufacturer should be contacted for advice.

An AI must obtain valid consent from any individual being vaccinated and/or their parent/guardian. As part of informed consent, a pre-vaccination screening must be completed prior to administering a vaccine to identify if contraindications or precautions to vaccination exist. 

A pre-vaccination screening checklist is included in the AIH and must be completed prior to all vaccinations. It is recommended that the AIR is routinely checked as part of pre-vaccination screening to avoid vaccination administration errors (e.g. incorrect dose intervals or dose numbers being administered).

Prior to obtaining consent, the individual or the parent/guardian of the individual being vaccinated, should be:

• supplied information (preferably written) which includes the risks and benefits relating to the vaccine, and the vaccination procedure and what to do in the event of side effects following vaccination
• notified that the individual’s vaccination record will be reported to the AIR.

AIs should have a process to obtain and document individual consent, and to ensure that individual privacy and confidentiality are always upheld. 

Consent on behalf of a child or adolescent

In general, a parent or legal guardian of a child or adolescent has the authority to consent to that individual being vaccinated. 

Some Australian states and territories have legislation that addresses the issue of a child’s consent to medical treatment. The common law applies in the states and territories that do not have specific legislation relating to children’s consent to medical treatment. This common-law position is often referred to as Mature Minor or Gillick Competence.

For certain procedures, including vaccination, a child or adolescent may be determined to be mature enough to understand the proposed procedure, and the risks and benefits associated with it. These young people may have the capacity to consent under certain circumstances.

As outlined in the AIH, where the parent and/or guardian of the individual being vaccinated is not present, AIs must assess whether the individual is mature enough and has the capacity and sufficient maturity to understand the advice and implications of the vaccine and consent to the procedure.

AIs who elect not to administer a vaccine based on their assessment of the individual’s maturity and understanding should refer the individual back to their medical practitioner.

If a child or adolescent refuses a vaccination that a parent and/or guardian has provided consent for, respect the child/adolescent’s wishes. Do not vaccinate and inform the parent or guardian.

Post-vaccination observation

The AI must advise the individual or the individual and their parent and/or guardian to remain on the premises for a minimum of 15 minutes post-vaccination, to allow for immediate assistance in the event of an AEFI.

The AI must either observe, or direct an appropriate person to observe, the vaccinee for 15 minutes after vaccination for acute adverse events or anaphylaxis.

The AI must inform the individual, or the parent/guardian of the person being vaccinated, of the potential risks associated with leaving during the post-vaccination period and put a note in the record of vaccination if the individual chooses to do so.

If a vaccinated person begins to display signs and symptoms of anaphylaxis, typically within 15 minutes of receiving a vaccine, a dose of adrenaline should be administered as soon as possible, and an ambulance called. The risk of death due to anaphylaxis is far greater than the risk posed by administering a dose of adrenaline.

Record keeping

Consent forms and vaccination records must be retained in a form that can be recovered and printed for a minimum of seven years, or longer. These documents should be stored in a format and location that allows timely access, easy retrieval and protects individual confidentiality. Records must be retained and provided in accordance with the relevant legislation and regulations. 

All Tasmanian AIs are required to comply with the record-keeping requirements, relevant legislation, and the documentation recommendations of the AIH. They must record the following details for each vaccine administered:

• time and date of the vaccination
• name, form, and strength of the vaccine, including brand name, batch number and dose number
• name, date of birth and address of persons to whom the vaccine is administered
• name and contact details of the AI carrying out the administration
• injection site and route
• date the next vaccination is due (if applicable)
• any adverse events observed or reported (including delayed responses).

Immunisation registers

The AIR is a national register that records vaccinations given to people of all ages in Australia.

Vaccination Providers must register with the AIR as part of the requirements to provide a vaccination service in Tasmania. 

Registration forms are available from the Australian Government Services Australia webpage.

• Under the AIR Act (2015), it is mandatory to report all NIP funded, influenza and COVID-19 vaccine encounters to the AIR. It is strongly recommended that all private and state funded vaccine encounters are also uploaded to the AIR.

NIP vaccine reporting

For further information about the AIR and reporting vaccinations visit Australian Immunisation Register for Health Professionals

3All vaccination providers are required to report on NIP vaccine use and stock on hand prior to ordering vaccines, this includes vaccine wastage (i.e. expired stock) and leakage (vaccines given to non-eligible patients). This is to ensure Tasmania meets the national reporting requirements as part of the NIP agreement. The CDPU is the custodian for NIP vaccines in Tasmania.

All NIP vaccine providers are subject to random audits, including for vaccine use, orders, wastage and cold chain management.

Complaints

The Department reserves the right to revoke or terminate authorisation of any AI or organisation who demonstrates unsatisfactory conduct. Where necessary, serious deviations from acceptable professional standards will be reported to the appropriate organisation for their consideration.

Organisations should have a process for complaints regarding vaccination services. 

• Complaints relating to an AI’s professional practice should be directed to the Ahpra  by phoning 1300 419 495 or visiting the Ahpra  website at www.ahpra.gov.au.
• Complaints relating to the vaccination setting should be directed to the Immunisation Unit, Tasmanian DoH by email at [email protected]or via phone 6166 0632. 

Contact Us

If you have any questions regarding these guidelines or for clinical guidance, please contact the Immunisation Unit, CDPU, via email: [email protected] or via phone on (03) 6166 0632.